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Protocol Summary


Protocol No.
PSHCI-15-025
Prinicipal Investigator
Lipton, Allan
Phase
NA
Age Group
Adult
Scope
National
Secondary Protocol No.
IRB # 00001959
Title
Predicting Breast Cancer Metastasis: Signaling Pathway Biomarker Identification Using Reverse Phase Protein Microarray (RPMA) Technology
Objective
Generation of the breast cancer metastasis protein signature:
Cohort A (Test Cohort): Primary and Metastatic tumors (from Relapsing patients) (n=100): Primary breast cancer and matching metastatic sites from the same patient.
Cohort B (Test Cohort): Primary breast tumors only (from Non-Relapsing patients) (n= 100): (No relapse within 2 years).
Procedure: The RPMA protein profile differences between Cohorts A and B will be statistically optimized to generate the receptor/pathway activation signature that best discriminates breast cancer patients destined for relapse (develop distant metastasis ) vs those patients not destined for relapse.

Validation of the breast cancer metastasis protein signature: Primary breast cancers only from additional cohorts of Relapsing (Cohort C) (n=100) and Non-Relapsing (Cohort D) (n=100) patients will have RPMA analysis conducted in blinded fashion. The RPMA metastatic receptor/pathway activation signature obtained from Cohorts A and B above will then be employed to evaluate the specificity of this signature in differentiating non-relapsing from relapsing primary breast cancers in Cohorts C and D.
Applicable Disease Sites
Breast - Female
Status
Open
Participating Institutions
Hershey Medical Center
Contact
Name
Kim Leitzel
Phone No.
+1 717-531-8101
E-mail
kleitzel@hmc.psu.edu